title: Safety of Trans Vaginal Mesh procedure: retrospective study of 684 patients.
abstract: OBJECTIVE
  To study peri-surgical complications after cure of genital prolapse by vaginal route using interposition of synthetic prostheses Gynemesh Prolene Soft (Gynecare) following the Trans Vaginal Mesh (TVM) technique.
  
  
  METHODS
  The present retrospective multicentered study comprised 684 patients who underwent surgery at seven French centers between October 2002 and December 2004. All patients had a genital prolapse >or=3 (C3/H3/E3/R3) according to International continence society (ICS) classification. According to each case, prosthetic interposition was total, or anterior only or posterior only. Patients were systematically seen 6 weeks, 3 months and 6 months after surgery. Multivaried statistical analysis followed a model of logistic regression applied to each post-surgical complication.
  
  
  RESULTS
  The mean age of patients was 63.5 years (30-94). The mean follow-up period was 3.6 months. 84.3% of patients were post-menopause, 24.3% had hysterectomy, 16.7% previous cure of prolapse, and 11.1% cure of stress urinary incontinence (SUI). During the procedure, hysterectomy was combined in 50.3% of cases, cervix amputation in 1.5%, and cure of SUI in 40.9%. 15.8% were treated for a cystocele only. 14.8% had only a rectocele +/- elytrocele and 69.4% had a prolapse touching both compartments, anterior and posterior. In peri-surgical complications, (2%) were five bladder wounds (0.7%), one rectal wound (0.15%) and seven hemorrhages greater that 200 mL (1%). Among early post-surgical complications (during the first month after surgery) (2.8%) were two pelvic abscesses (0.29%), 13 pelvic hematomas (1.9%), one pelvic cellulitis (0.15%), two vesicovaginal fistulas and one rectovaginal fistula (0.15%). Among late post-surgical complications (33.6%) there were 77 granulomas or prosthetic expositions (11.3% [6.7% in the vaginal anterior wall, 2.1% in the vaginal posterior wall and 4.8% in the fornix]), 80 prosthetic retractions (11.7%), 36 relapse of prolapse (6.9%) and 37 SUI de novo (5.4%). Multivaried analysis shows that previous history of hysterectomy or placing of an isolated anterior prosthesis increase the risk of peri-surgical complication; preserved uterus and isolated posterior prosthesis lessen the risk of granulomas and prosthetic retractions; and association of a Richter's intervention increases the rate of prosthetic retractions.
  
  
  CONCLUSIONS
  Cure of genital prolapse with synthetic prostheses interposed by vaginal route is now reliable and can be reproduced with a low rate of peri- and early post-surgical complications. However, our study shows a certain number of late post-surgical complications after insertion of strengthening synthetic vaginal implants (prosthetic expositions and prosthetic retractions). These retrospective results will soon be compared to a prospective study.
authors.affiliation: Gynaecological Surgery, Hospital Jeanne de Flandre, Lille Cedex, France.
authors.forename: Fréderic
authors.initials: F
authors.lastname: Caquant
authors.forename: Pierre
authors.initials: P
authors.lastname: Collinet
authors.forename: Philippe
authors.initials: P
authors.lastname: Debodinance
authors.forename: Juan
authors.initials: J
authors.lastname: Berrocal
authors.forename: Olivier
authors.initials: O
authors.lastname: Garbin
authors.forename: Claude
authors.initials: C
authors.lastname: Rosenthal
authors.forename: Henri
authors.initials: H
authors.lastname: Clave
authors.forename: Richard
authors.initials: R
authors.lastname: Villet
authors.forename: Bernard
authors.initials: B
authors.lastname: Jacquetin
authors.forename: Michel
authors.initials: M
authors.lastname: Cosson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000379:methods; D006801:Humans; D008875:Middle Aged; D011126:Polypropylenes / Q000627:therapeutic use; D012189:Retrospective Studies; D013526:Surgical Mesh / Q000009:adverse effects*; D014596:Uterine Prolapse / Q000601:surgery*
chemical_list: D011126:Polypropylenes